Pronunciation:

doe-LAS-e-tron MES-i-late

Brand Names:

• Anzemet

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Dolasetron

Uses of This Medicine:

Dolasetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. Dolasetron works to block the signals to the brain that cause nausea and vomiting.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dolasetron in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolasetron in the elderly. However, elderly patients are more likely to have heart rhythm problems, which may require caution in patients receiving dolasetron.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine
• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Levomethadyl
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Adagrasib
• Ajmaline
• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anagrelide
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Benzhydrocodone
• Benzphetamine
• Bretylium
• Brompheniramine
• Buprenorphine
• Buserelin
• Buspirone
• Butorphanol
• Carbamazepine
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Encorafenib
• Enflurane
• Entrectinib
• Erythromycin
• Escitalopram
• Fenfluramine
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fostemsavir
• Frovatriptan
• Furazolidone
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Iproniazid
• Isocarboxazid
• Isoflurane
• Isradipine
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lacosamide
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lopinavir
• Lorcainide
• Lorcaserin
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Metronidazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Mobocertinib
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pirmenol
• Pitolisant
• Ponesimod
• Posaconazole
• Prajmaline
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Remifentanil
• Ribociclib
• Risperidone
• Rizatriptan
• Selegiline
• Selpercatinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Toremifene
• Tramadol
• Tranylcypromine
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Tryptophan
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vortioxetine
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or
• Congestive heart failure or
• Kidney disease—Patients with these conditions should be monitored with an electrocardiogram (ECG) while using this medicine.

• Congenital long QT syndrome (abnormal heart rhythm) or
• Heart block, without a pacemaker—Should not be used in patients with these conditions.

• Heart disease or
• Heart rhythm problems (eg, atrial fibrillation, prolonged QT, PR, and QRS interval) or
• Sick sinus syndrome (type of abnormal heart rhythm)—Use with caution. May increase risk for more serious heart rhythm problems (such as torsade de pointes) and additional monitoring is required.

• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Must be corrected first before using this medicine.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If your child cannot swallow the tablets, the injection solution can be mixed with apple or apple-grape juice and taken by mouth. The mixture may be stored for up to 2 hours at room temperature before use.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of nausea and vomiting after cancer medicines:
    • Adults—100 milligrams (mg) given within 1 hour before starting cancer treatment.
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.8 milligrams (mg) per kilogram (kg) of body weight given within 1 hour before starting cancer treatment. However, the dose is usually not more than 100 mg.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

This medicine can cause changes heart rhythms, such as conditions called QT, PR, and QRS prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have a fast, pounding, or irregular heartbeats.

Dolasetron may cause a serious condition called serotonin syndrome if taken together with some medicines such as fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), a MAO inhibitor (such as methylene blue injection, Eldepryl®, Marplan®, Nardil®, Parnate®), medicine to treat migraine headaches, or medicine to treat depression (eg, fluoxetine, mirtazapine, paroxetine, Celexa®, Effexor®, Lexapro®, Paxil®, Zoloft®). Check with your doctor first before taking any other medicines with dolasetron.

Do not stop taking this medicine without checking first with your doctor. Your doctor may gradually reduce the amount you are using before stopping completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain or discomfort

lightheadedness, dizziness, or fainting

slow or irregular heartbeat

unusual tiredness or weakness

Less common

Chills

decrease in the amount of urine

fast, pounding, or irregular heartbeat or pulse

fever

Rare

Agitation

black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

burning while urinating

changes in skin color

confusion

cough

delirium

depression

diarrhea

difficult or labored breathing

difficult or painful urination

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of warmth

feeling uncoordinated

frequent urination

hallucinations

headache

hives or welts, itching, or skin rash

increased volume of pale, dilute urine

irritability

lethargy

muscle twitching

nausea

noisy breathing

numbness and tingling of the face, fingers, or toes

pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion

pain, tenderness, or swelling of the foot or leg

pale skin

pale, bluish-colored, or cold hands or feet

pinpoint red or purple spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

red skin

rigid muscles

seizures

sweating

swelling of the face, ankles, or hands

tightness in the chest

tingling of the hands or feet

tremor

troubled breathing with exertion

unusual bleeding or bruising

unusual weight gain or loss

vomiting

weak or absent pulses in the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Belching

heartburn

indigestion

pain

stomach discomfort, upset, or pain

Rare

Abnormal dreams

bad, unusual, or unpleasant (after) taste

bloating

bloody nose

change in taste

changes in vision

continuing ringing or buzzing or other unexplained noise in the ears

darkened urine

difficulty having a bowel movement (stool)

difficulty seeing at night

difficulty with moving

feeling of constant movement of self or surroundings

feeling of unreality

hearing loss

increased sensitivity of the eyes to sunlight

increased sweating

joint pain

loss of appetite

muscle aching or cramping

muscle pain or stiffness

pain or burning sensation at the injection site

pains in the stomach, side, or abdomen, possibly radiating to the back

redness of the face, neck, arms, and occasionally, upper chest

sensation of spinning

sense of detachment from self or body

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

swollen joints

unsteadiness, trembling, or other problems with muscle control or coordination

weight loss

yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.